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A project or challenge comes up and many people, without thinking, immediately form a team to research, solve the problem and implement the solution. Teams can be a

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

very powerful way to solve problems and implement massive improvements. But teams aren’t the right answer to every situation.

To get the best possible results fro

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

m the resources available, it is important that a leader answer a question they typically don’t ask - “Is a team the best way to address this situation?”

Unfortunat

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ely when they assume the answer to that first question they jump to “Who should I put on the team?” When they start there, they may have already doomed the organiza

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ion to less than the perfect solution, before they even get started.

This article poses five questions designed to help you answer this important first question.

<

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

b>Is the goal clear? If the goal isn’t crystal clear yet, don’t form a team. A team can develop a problem statement and solve a problem, but they can’t work su

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ccessfully (at least not quickly and efficiently) with a goal that isn’t clearly articulated. Once the goal is clear (you might want to meet with a couple of people

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

in a one time meeting to get this clarity), you can continue on with the rest of the questions. Until then, don’t form a team!

Will the team have the resources

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

hey need to succeed? You may be the person who needs to provide those resources, or you may need to negotiate for them. Teams need to know what resources they

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

have in terms of skills, budget, time, support and more. While a lack of resources will challenge people and teams to be creative, there is a limit to this! Teams w

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ill falter and struggle without the necessary resources to succeed. Proceed with out them and you risk massive frustration and low productivity.

Does this reall

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

y require a team? This is perhaps the biggest of the questions. We all value collaboration and teamwork – but they don’t have to go together. Collaboration c

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

n be achieved without a team. Perhaps what you need to do is assign or find a person to run a project, and encourage others with valuable input and experience to co

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

llaborate and help as needed. Remember there is a big difference between putting people on a team and asking them to help on an as-needed basis. When you remember

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

that you can foster collaboration without a team you allow yourself to really answer this question successfully.

What is the relative importance? Not all pr

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ojects or problems are created equal. It is important to consider the relative importance of a situation before dedicating lots of resources to it. Think about you

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

overall plan and your people resources. See where this fits into your big picture before you decide to form a team, versus assigning it to a single person to manag

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

e.

Is there time? It takes time to schedule, form, acclimate and help a team get a good start. Is there time for all that, relative to the need for a soluti

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

on or answer? If not, get someone, get and decision and move on.

If you get yes answers to all of the questions above, congratulations! Form your team and help th

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

em succeed.

But if you get one or more no answers - do yourself and those you might put on a team – a favor. Think a bit longer before automatically forming a team

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Especially for teachers. Ideas on how to customize your cover letter to specifically appeal to the school system you are applying to.

Average medical practice may lose as much as 11% of its revenue due to underpayments. Underpayment identification is difficult because an underpaid claim falls outside the domain of clearly identifiable claims that are fully paid or denied. The degree of underpayment adds further complexity to and exacerbates the difficulty of underpayment identification. Upon defining claim underpayment concept in more precise terms, this article roughly estimates recovery potential at 5% of monthly claims volume. Quantification of recovery potential drives the design of a disciplined three-stage underpayment avoidance and recovery process.

Are you a frustrated financial services salesperson in the Business of Busy-ness instead of Sales? This article cuts through the challenges and talks indepth about 4 ways to keep your busy-ness profitable and 3 priorities to keep you on track to more closings and greater profits.

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